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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00958100
Other study ID # 2009-014316-35
Secondary ID
Status Completed
Phase Phase 2
First received August 12, 2009
Last updated February 3, 2015
Start date August 2009
Est. completion date December 2010

Study information

Verified date February 2015
Source Catholic University of the Sacred Heart
Contact n/a
Is FDA regulated No
Health authority Italy: The Italian Medicines Agency
Study type Interventional

Clinical Trial Summary

This study aims to verify the persistent control of the virus replication at 48 weeks after the simplification to tenofovir + emtricitabine + raltegravir or to lamivudine+abacavir+raltegravir in patients with optimal virological suppression without any virological failure to previous combined antiretroviral therapies needing a therapeutic switch for toxicity related issues or adverse events.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients treated with a combined antiretroviral therapy from at least 1 year

- Aged 18 years or older

- With one or more of the following conditions:

- Grade 3 or 4 Dyslipidemia

- Any Hyperglycemia

- Lipodystrophy (patient's self report, confirmed by physician's physical examination)

- Moderate/severe cardiovascular risk, defined as a calcium score higher than 40 or a Framingham score higher than 10 (estimated 10 years cardiovascular risk: 10%)

- Diarrhea (at least 3 emissions of loose stool every day for at least 3 days every week)

- With at least two HIV-RNA levels <50 copies/mL on two consecutive determinations at least 3 months apart

- With CD4 cell count >200 cells/ µL for at least 6 months and absence of any opportunistic infection or AIDS-related disease during the last year before screening.

- Who gave informed consent to the participation to the study

Exclusion Criteria:

- Pregnancy or breast feeding, desire of pregnancy in the short term

- Previous virological failure (two consecutive HIV-RNA levels > 50 copies/mL or a single value >1000 copies/mL) to antiretroviral therapy and/or previous exposure to mono- or dual therapies with reverse transcriptase nucleoside analogues except for patients with subsequent genotypic resistance tests showing no resistance mutations to any of the study drugs.

- Previous exposure to inhibitors of HIV-1 integrase

- Previous major toxicity to any of the study drugs

- Spontaneous treatment interruptions in disagreement with the treating physician in the last year or loss to follow-up for at least 6 months, at least once in the last two years

- Current alcohol or drug abuse or any other condition which, in the judgment of the treating physician, may impair the patient's adherence to the new drug regimen and/or to the protocol's procedures

- Patients with grade 3 or 4 laboratory abnormalities at screening (except for lipid and glucose levels)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
tenofovir emtricitabine raltegravir
switch from current antiretroviral regimen to raltegravir with tenofovir/emtricitabine as backbone
Lamivudine Abacavir Raltegravir
Switch from current antiretroviral regimen to raltegravir with abacavir/lamivudine as backbone
Abacavir free
Patients will receive raltegravir with tenofovir/emtricitabine; data will be added to those of Tenofovir Emtricitabine Raltegravir arm in a separate longitudinal analysis comparing data at baseline and at 48 weeks. In this separate analysis, data will not be compared to those obtained from the Lamivudine Abacavir Raltegravir arm. The number of patients in this arm is not pre-established.

Locations

Country Name City State
Italy Policlinico A. Gemelli Rome

Sponsors (1)

Lead Sponsor Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary To verify the persistent control of the virus replication after the simplification to tenofovir+emtricitabine+raltegravir or to lamivudine+abacavir+raltegravir in patients with optimal virological suppression without any previous virological failure 48 weeks No
Secondary Time to virological failure (two consecutive HIV-RNA levels > 50 copies/mL or a single value >1000 copies/mL) at survival analysis 48 weeks No
Secondary Proportion of patients with viral load lower than 50 copies/mL at 48 weeks at the intention to treat analysis 48 weeks No
Secondary Evolution of CD4 cell count during the 48 weeks of study 48 weeks No
Secondary Evolution of adherence and quality of life during the 48 weeks of study 48 weeks No
Secondary Evolution of raltegravir plasma concentrations during the 48 weeks of study 48 weeks No
Secondary Evolution of metabolic parameters during the 48 weeks of study 48 weeks Yes
Secondary Change of the results of neurocognitive tests at 48 weeks of study 48 weeks Yes
Secondary Change of bone density and of adipose tissue by DEXA analysis at 48 weeks of study 48 weeks Yes
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